Anti-hepatitis C virus (HCV) immunochromatographic assay (ICA) is commonly used as an early screening test for HCV infection. This study evaluated the influence of test parameters (technician, assay type, kit lot, temperature, and humidity) on the performance of anti-HCV ICA. The anti-HCV results were collected in 2016–2018 by two ICA assays (Humasis HCV card [Humasis Co. Ltd., Korea] and Asan Easy Test HCV [Asan Pharmaceutical, Korea]) (N=55,919). Anti-HCV ICA-positive samples (N=639) were retested using Architect anti-HCV (Abbott Laboratories, Germany). There were statistically significant differences in the retest signal to cutoff (S/CO) ratios of anti-HCV ICA-positive samples among the groups with different technicians and kit lots (P<0.05). The positive rates of anti-HCV ICA were statistically significantly different according to indoor humidity levels (P=0.0405). These findings suggest that there is a need for clinical laboratories to manage the performance of anti-HCV ICA with acceptable ranges of positive rates and utilize the S/CO ratio to evaluate the influence of test parameters.

Keywords: Hepatitis C virus, Hepatitis C antibodies, Immunochromatographic assay, Performance, Evaluation